Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer Metastatic to Liver; Oligometastasis

Treatments: Combination Product: Microwave Ablation combination with chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04677192

PCLM-A 2020

Details and patient eligibility

About

This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.

Full description

Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 to 75years old, male or female;

• ECOG PS: 0-2 points;

• Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;

• Expected survival time> 3 months;

• The functions of important organs meet the following requirements;

• The maximum diameter of single lesion ≤ 5cm or the number of multiple lesions ≤ 5 and the maximum diameter ≤ 3cm;

• Measurable lesions that meet RECIST criteria.

  1. Platelet ≥75×109/L, hemoglobin ≥85g/L，white blood cell ≥ 3.0 × 109 / L;
  2. Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
  3. Albumin ≥ 28g / L;
  4. Creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50ml / min;

• Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 3 months after the last dose of treatment Contraceptive measures;

• Signature of patient information and informed consent.

• Patients who did not participate in other clinical trials within 4 weeks before screening; those who failed in other trials but met the requirements of this trial could be enrolled.

Exclusion criteria

• Patients with distant metastasis include but not limited to lung metastasis, bone metastasis and brain metastasis;
• Other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina, myocardial infarction and cerebral infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, drug abuse, etc;
• Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
• During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
• In addition to cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis & T1). Any cancer cured for more than 3 years before enrollment was allowed to be enrolled;
• Patients who cannot follow the trial protocol or cannot cooperate with follow-up;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Microwave Ablation Combined with Chemotherapy

Experimental group

Description:

All patients will receive microwave ablation of oligohepatic metastasis and chemotherapy according to NCCN guidelines,and the efficacy was evaluated every 8 weeks until the disease progressed or the patient could not tolerate it.

Treatment:

Combination Product: Microwave Ablation combination with chemotherapy